RecruitingPhase 1NCT05010005

A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

70 participants

Start Date

Aug 12, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test the safety of ruxolitinib, given at one dose that does not change, and duvelisib, given at different doses, to find out what effects, if any, the study treatment has on people with relapsed or refractory NK-cell or T-cell lymphoma. This study has three parts: dose escalation (Part 1), dose expansion (Part 2), and TFH/T-PLL cohort expansion (Part 3).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — ruxolitinib (a JAK inhibitor) and duvelisib (a PI3K inhibitor) — in people with T-cell lymphomas or other rare T-cell or NK-cell blood cancers that have come back or stopped responding to previous treatments. **You may be eligible if...** - You have a confirmed diagnosis of a T-cell lymphoma (such as cutaneous T-cell lymphoma/CTCL, anaplastic large cell lymphoma, T-cell prolymphocytic leukemia, or related conditions) - Your cancer has relapsed or not responded to prior treatment - For some histologies (like CTCL), you need to have tried at least 2 prior therapies - For T-cell prolymphocytic leukemia, no prior treatment is required **You may NOT be eligible if...** - You do not have a confirmed qualifying T-cell or NK-cell lymphoma diagnosis - You have not tried the required prior treatments (for most subtypes) - Your general health or organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

Ruxolitinib 20mg BID

DRUGDuvelisib

Duvelisib 25mg, 50mg, or 75mg BID


Locations(9)

University of Miami (Data Collection Only)

Miami, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05010005


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